- InFoods®
IBS Data Receives American College of Gastroenterology Presidential Award (ACG) Following Presentation at Annual Scientific Meeting
- Trial Data Shows InFoods® IBS Treatment Diet Significantly Improved Several IBS Symptoms Including Abdominal Pain Intensity (API): In Some Cases Better Than Certain Currently Marketed Drugs
- Launch of InFoods® IBS Lab Developed Test Expected in Fiscal 3Q
- Amazon Now Fulfills Sales of Aware® Breast Self Exam and EZ Detect™ Colon Disease Tests
Net sales for the three months ended
Key Developments During the Quarter:
- InFoods® IBS launch: the Company is working to launch the InFoods IBS laboratory developed test with large GI groups and expects initial revenues from the launch of this product during fiscal Q3 which ends
February 28, 2023 . Rather than simply treating the symptoms of IBS, the InFoods® IBS platform is designed to identify the unique foods that trigger or worsen IBS symptoms in individual patients, paving the way for more effective treatment. It is estimated that over 40 million Americans suffer from IBS, with symptoms often triggered by consumption of specific foods (which are unique in each sufferer). The total direct and indirect cost of IBS has been estimated at$30 billion annually inthe United States alone. - InFoods®: In the data presented at the ACG annual meeting for the Abdominal Pain Intensity (API) responder endpoint of >30% improvement in pain, patients with IBS Constipation and IBS Mixed in the treatment diet arm had a statistically significant improvement over patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and is similar and, in some cases, better than the current drugs in the market.
- H. pylori: After discussions with the FDA, the Company has been asked to run one additional set of tests in-house on the
Biomerica hp+detect™ before the FDA can move to clear the product.Biomerica is in the process of running these tests and submitting the results to the FDA. TheBiomerica hp+detect™ product is designed to detect the presence of the H. pylori bacteria which infects approximately 35% of theU.S. population. Over 80% of gastric cancers are attributed to H. pylori infection, and gastric cancer is the third most common cause of cancer-related death worldwide. - Walmart & Aware: During the quarter Walmart began online and in-store sales of the FDA cleared Aware® Breast Self Exam device. About 80% of breast cancers are detected because women themselves notice changes in their breasts, highlighting the important role that each woman can play in her own health. The Aware® Breast Self Exam device is designed to allow women to enhance tactile sensitivity to changes or irregularities in breast tissue, making breast self-exams easy and convenient.
- EZ Detect and Aware International Approvals: The Company received clearance from the Kingdom of
Saudi Arabia Food and Drug Administration (KFDA), and theUnited Arab Emirates (UAE) Ministry of Health and Prevention (MOHAP) for the EZ Detect™ Colon Disease test and the Aware® Breast Self Exam device. The Company is working with distribution partners to launch the products in these countries and throughout theMiddle East andNorth Africa (MENA) regions.
“We are optimizing the process for GI physicians to order and receive results from the InFoods IBS test for their patients. We believe ease of order and work flow for physicians, with easy to understand and actionable results for patients, is critical to our success. At the same time, we are very honored to be recognized and awarded by the esteemed
About
About InFoods®
The Biomerica InFoods® IBS product is designed to allow physicians a new precision medicine approach to identify patient-specific foods (e.g., eggs, broccoli, wheat, potatoes, pork, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, cramping, pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a guided dietary regimen to improve IBS outcomes. A point-of-care version of the product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product is expected to be the first for which the Company will launch and seek regulatory approval. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects. An estimated 40 million people in America currently suffer from IBS making it a leading cause for patient doctor visits1.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s estimated future financial results, physician and patient demand for the Company's products, the Company's ability to fulfill orders, and possible success of our products in the market, and the possible regulatory approvals needed to sell the company’s products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s InFoods® products, hp-detect® test and other products and tests; actual efficacy of the Company’s InFoods® products, hp-detect® test and other products and tests; expected completion of clinical studies and trials; the rapidity of testing results; uniqueness of the Company’s products; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® test and other products and tests, including FDA clearance, attaining CE Mark and approvals from other international regulatory agencies; availability of the Company’s test kits and other products; capacity, resource and constraints on our suppliers; efficacy of the Company’s InFoods® products, hp-detect® test and other products and tests; regulatory approvals necessary prior to commercialization of the Company’s hp+detect® test, InFoods IBS® test and other products and tests; dependence on our suppliers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that could make it difficult or impossible for the company to maintain current operations; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold and the Company’s ability to obtain patent protection and freedom to operate on any aspects of its rapid test technologies; future production costs and overhead, sales and administrative costs, R&D expenditures, materials costs, needed inventory reserves, collectability of receivables, legal costs and other extraordinary costs. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of
1. Canavan et al. The epidemiology of irritable bowel syndrome Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245
Corporate Contact:
949-645-2111
zirani@biomerica.com
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